N/A
N=25
Improving Treatment and Retention Adherence in Nontraditional Settings
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT04973254 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Adherence to Cabenuva Injections — 1; 17; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CAB-RPV LA (Other); Standard treatment within an HIV clinic (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to Cabenuva Injections |
1; 17; 0; 1; 17; 0 | — |
| PRIMARY Adherence to Primary Care Appointments |
5; 17; 0; 2; 16; 0 | — |
| PRIMARY Adherence to Mental Health/Behavioral Appointments |
2; 4; 0; 1; 3; 0 | — |
| PRIMARY Adherence to Substance Abuse Appointments in Cohorts 1 and 2 |
5; 0; 0; 2; 0; 0 | — |
Summary
This is a hybrid implementation-effectiveness study using both qualitative and quantitative methods. The research aims to examine whether providing a new, but approved, HIV once a month injection treatment [Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA)] to individuals who are living with HIV outside of the standard doctors office or clinic increases adherence to treatment. This HIV monthly injections treatment which is already being delivered within the clinic setting, will be administered to participants in community partner spaces, reducing the barriers that having to present to a traditional clinic for treatment creates.
Individuals who will receive the injection need to have a history of being unable to take their HIV oral medication, as well as other barriers to care that make it difficult to engage in a traditional clinic setting. These barriers may include, but are not limited to, homelessness, substance use, mental illness, and stigma around their diagnosis.
Data will be collected on whether it was easier for the participants to receive care in a non-traditional setting, as well as whether the injection made it easier for them to remain adherent to their HIV medication in comparison to standard oral HIV medication.
Eligibility Criteria
Inclusion Criteria for Cohort 1:
- HIV-positive
- English or Spanish speaking
- Lab values that indicate the patient is a candidate for the medication and virally suppressed
- Willing to complete the locator form to receive appointment reminders prior to follow-up data collection
Inclusion Criteria for Cohort 2:
- HIV-positive
- English or Spanish speaking
- Enrolled in care and receiving CAB-RPV LA injection at Boston Medical Center Infectious Disease Clinic (HIV clinic)
- Willing to complete the locator form to receive appointment reminders prior to follow-up data collection
Inclusion Criteria for Cohort 3:
- HIV-positive
- English or Spanish speaking
- Enrolled in care but NOT receiving CAB-RPV LA injection at Boston Medical Center Infectious Disease Clinic (HIV clinic)
- Willing to complete the locator form to receive appointment reminders prior to follow-up data collection
- Matched to participants demographically and in terms of other characteristics in Cohort 1 at a 2:1 ratio
Exclusion Criteria (for all 3 cohorts unless stated):
- Not virally suppressed prior to beginning CAB-RPV LA (does not apply to cohort 3)
- A history of adhering fully to their antiretroviral therapy (ART)
- Not willing to take CAB-RPV LA after detailed discussion of what the use of CAB-RPV LA will entail (does not apply to cohort 3)
- Unable to undergo clinical eligibility testing to confirm eligibility (does not apply to cohort 3)
- A history of integrase inhibitor mutations suggesting resistance to Cabotegravir or Cabenuva
- A history or evidence of resistance to either integrase strand transfer inhibitor (INSTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) HIV drugs
- Currently pregnant or breastfeeding
- Currently has HIV 1 with an HIV 2 co-infection or an HIV 2 infection
- Taking any drugs that have known interactions with Cabenuva, including but not limited to carbamazepine, oxcarbazepine, phenobarbital, phenytoin, St Johns Wort, systemic Dexamethasone, rifabutin, rifampin and rifapentine
- Chronic Hepatitis B infection
Data sourced from ClinicalTrials.gov (NCT04973254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.